MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY HOOK

Model Number 470183-14

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook (pch) instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.The instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.The root cause of this failure is attributed to a component failure.Additional observation(s) not reported by site: the instrument was found to have a dislodged flush tube.Root cause of this failure is attributed to mishandling.The instrument was found to have thermal damage on of the distal clevis ears.The instrument passed an electrical continuity test.The instruments conductor wire was not damaged.The root cause of this failure is attributed to mishandling.A review of the instrument log for the pch instrument (part # 470183-14 / lot # n11190923-0041) associated with this event has been performed.Per logs, the pch was last used on 30-nov-2020 on system sl0565, with 2 uses remaining.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No photo or video was provided by the site for review.This complaint is being reported due to the following conclusion: this instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall inside the patient.Although there was no patient injury, the product malfunction identified through failure analysis could cause or contribute to an adverse event if the failure were to recur.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the permanent cautery hook instrument did not follow the movements of the surgeon and the wire from the wrist was cut.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11214250
• MDR Text Key: 230960803
• Report Number: 2955842-2021-10073
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)N11190923
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N11190923 0041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1